CMSA Blog - Lessons from the recent Meningitis Outbreak
April 22, 2013 - Michael Yohannes
Following the New England Compounding Center’s tainted steroids were linked last fall to meningitis and other infections,surprise state inspections at 37 specialty pharmacies in Massachusetts show that only four have been fully complying with Compounding Pharmacies safety standards. It is very daunting to see that only a fraction of the state’s sterile compounding pharmacies were obeying all the rules. It’s clear that we need to resolve the safety issues raised by Compounding Pharmacies across the board, if not, this will certainly happen again.
These findings underscore concerns about the risk of drug contamination not only in Massachusetts, but also in other states. Throughout the US, Compounding Pharmacies are not inspected and not held accountable to the highest standards. Compounding Pharmacies have usually been overseen by state Pharmacy Boards. However, Pharmacy Boards in nearly all states lack the information and expertise to oversee specialty pharmacies like the one that triggered the deadly meningitis outbreak last year. Many states do not keep any inspection records of compounding pharmacies. And, the majority of states do not train their inspectors to recognize problems with sterile compounding.
Pharmacists in different professional settings provide compounding services. The public, along with health care professionals, trust pharmacists to compound different products, which include creams, ointments and sterile compounding, which is the riskiest type of compounding. The recent outbreak may have shaken the public trust. If any good comes out of this tragic incident is that we have to reflect back and renew our commitment to patient safety. It is imperative that all pharmacies involved in compounding medications adhere to the very highest standards
Finally, state Pharmacy Boards should consider renewing their commitment to inspecting compounding pharmacies. Similar to what was recommended in Massachusetts, mandatory patient safety continuing education annually may need to be implemented across the states. And, a patient safety/quality professional be appointed to the Board of Pharmacy. These measures will increase regulatory oversight and enforcement of compounding pharmacies and will ensure Compounding Pharmacies adhere to high standards applied to compounding sterile medications.
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